Assyro AI

Orange Book product · Generic (ANDA)

SUMATRIPTAN

SUMATRIPTAN

Generic (ANDA)ANDA 208967TE ABRX REGCON HOLDINGS

At a glance

Feb 17, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 17, 2021

    5 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SUMATRIPTAN

Strength

20MG/SPRAY

Dosage form

SPRAY

Route

NASAL

TE code

AB

Application

ANDA 208967

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SUMATRIPTAN

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.